SOFI: A Quality Improvement Project to Standardize Use of Intravenous Fluids in Hospitalized Pediatric Patients

Intravenous fluids (IVF) are used in hospitalized patients to replenish the fluid and electrolyte losses of patients who cannot take adequate hydration by mouth or through their gut. Inappropriate use of IVF may cause serious problems, including abnormalities in blood electrolytes such as sodium, which can lead to serious but rare neurologic harm; pain and discomfort from multiple IV insertions and subsequent complications (e.g., IV infiltration); and inadequate monitoring for adverse effects.

Investigators currently don't know what the most commonly used IVF in hospitalized pediatric patients are, and there are no national benchmark data for IVF use. The American Academy of Pediatrics published a Guideline on maintenance IVF in November 2018, which contains one major recommendation: to use isotonic (having a similar electrolyte concentration to blood plasma) maintenance IVF in medical and surgical patients 28 days to 18 years old without pre-existing serious illnesses.

This project aims to better describe and standardize the use of IVF in inpatient pediatric settings across the U.S. and evaluate the impact of an intervention bundle on maintenance IVF use. This project aims to improve health care value by reducing the number of routine laboratory draws.

In Quality Improvement research, there are three different types of measures - outcome measures, process measures and balancing measures.

In this project, the following will be tested as process measures:

1. By May 2020, the proportion of daily weight measurements will increase by 10% from baseline for patients on maintenance IVF.

2. By May 2020, participants will attend an average of ≥75% of their scheduled sessions with project QI coaches. This will be measured by tracking attendance during coaching phone calls.

The following will be tested as balancing measures:

1. There will be no increase in the number of floor-to-PICU transfers during hospitalization from baseline.

2. There will be no increase in the number of serum sodium lab results obtained from baseline.

All sites will participate in a stepped wedge cluster randomized trial, with 80-120 sites total. This design is helpful when simultaneous implementation of an intervention is not feasible or practical, and allows for each site to collect baseline data for comparison with post-intervention data. There will be 3 groups (or clusters) of approximately 30-40 sites each, with randomization to intervention occurring at 2 month intervals. Randomization will be stratified by: geographic region, size and baseline rate of IVF use.

Overall Status

Active, not recruiting

Start Date

April 1, 2019

Completion Date

May 31, 2020

Primary Completion Date

May 31, 2020

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Fluid Tonicity

Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.

Routine Labs

Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.

Secondary Outcome

Measure

Time Frame

IVF duration

Monthly reports will be generated each month for each participating site through study completion, approximately 9 months.

Description:
Interventions will include:
Education (webinars) for physicians and nurses regarding AAP IVF guidelines, including evidence on safety of isotonic maintenance IVF
Implementation of algorithms, ordersets and checklists to guide choice of IVF and clinical indications to start/stop IVF;
Tools to promote discussion about timing and necessity of routine lab draws
Education and feedback for physicians regarding costs and harms of routine lab testing

Arm group label:
Stepped Wedge Group 2: Nov. 2019 Launch

Arm group type:
Active Comparator

Description:
Interventions will include:
Education (webinars) for physicians and nurses regarding AAP IVF guidelines, including evidence on safety of isotonic maintenance IVF
Implementation of algorithms, ordersets and checklists to guide choice of IVF and clinical indications to start/stop IVF;
Tools to promote discussion about timing and necessity of routine lab draws
Education and feedback for physicians regarding costs and harms of routine lab testing

Arm group label:
Stepped Wedge Group 3: Jan. 2020 Launch

Arm group type:
Active Comparator

Description:
Interventions will include:
Education (webinars) for physicians and nurses regarding AAP IVF guidelines, including evidence on safety of isotonic maintenance IVF
Implementation of algorithms, ordersets and checklists to guide choice of IVF and clinical indications to start/stop IVF;
Tools to promote discussion about timing and necessity of routine lab draws
Education and feedback for physicians regarding costs and harms of routine lab testing

Acronym

SOFI

Patient Data

No

Study Design Info

Allocation:
Randomized

Intervention model:
Crossover Assignment

Intervention model description:
All sites will participate in a stepped wedge cluster randomized trial. This design is helpful when simultaneous implementation of an intervention is not feasible or practical, and allows for each site to collect baseline data for comparison with post-intervention data. There will be 3 groups (or clusters) of approximately 30-40 sites each, with randomization to intervention occurring at 2 month intervals. Randomization will be stratified by: geographic region, size and baseline rate of IVF use. By the end of the project, all sites in all groups will have received the intervention toolkit.